Research Determination

STARS Tracking Number: 0900f3eb81aea9ba

NCEZID Tracking Number:

030520AG

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Investigation of a cluster of extensively drug resistant shigellosis associated with a cruise ship

Primary contact

Amanda Garcia-Williams

Division/Branch

DFWED/WDPB

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not require
submission to CDC’s Human Research Protection Office. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]
Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.

✔ Project is deemed not to be research under the following provision. IRB review is not required.
Public health surveillance activities, 45 CFR 46.102(l)(2)

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this activity is to investigate a cluster of XDR Shigella spp. associated with a
chartered Caribbean cruise in February. The objectives are to identify the source of the illness and
modes of transmission onboard the ship, identify community cases that are molecularly linked to the
cruise ship-associated cases, and describe the burden of illness in terms of clinical outcomes and
response to antibiotic treatment. This is an investigation designed to enable CDC to identify the
range and source of a disease outbreak, which is within the scope of Public Health Surveillance
activities deemed not to be research under §46.102(l)(2).
Additional considerations

Cruise ship passengers and community cases will be invited to participate in an online survey via e-mail. E-mails will be sent by the
cruise ship charter director (passengers) or by the health department (community cases). Respondents will be informed of the nature
and purpose of the survey, and they will demonstrate their consent by actively clicking the survey link. During the survey,
respondents have the option to permit or not permit CDC to share their survey responses with their local health department for
surveillance/public health purposes. Survey responses will not be shared with local health departments without an affirmative
response to this survey question.
Additional requirements

Some additional suggestions for the recruitment e-mail and survey intros have been provided under
separate cover. Once these materials have been finalized, you should be able to add them to
STARS without triggering a new review action. (Please call me if you need assistance.)
Changes in the nature or scope of this activity may impact the regulatory determination. Please discuss any changes with
your NC Human Subjects Advisor before they are implemented.
Reviewed by

Laura Youngblood

Laura Youngblood Signature S

Digitally signed by Laura
Youngblood -S
Date: 2020.03.05 13:43:48 -05'00'

Title

Human Subjects Advisor

Date 3/5/20